Stereotactic Radiosurgery in Treating Patients With Spinal Metastases

Boston Medical Center18 enrolled

Overview

RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. It may also help patients with spinal metastases live more comfortably. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with spinal metastases.

OBJECTIVES: * To implement CyberKnife® technology for improving palliation in patients with spinal metastases. * To determine the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in these patients. * To evaluate functional and diffusion MRI parameters in the spinal cord and tumor after treatment with Cyberknife® radiosurgery. OUTLINE: Patients undergo placement of gold fiducial markers at the time of open surgical resection or percutaneous needle biopsy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 30-90 minutes daily for 2-3 days. Patients undergo functional MRI and diffusion tensor imaging at baseline and then at 6 weeks and 6 months after completion of treatment. Patients also complete a pain questionnaire at baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment. After completion of study treatment, patients are followed periodically for up to 2 years.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Cancer

Interventions

questionnaire administrationOTHER

prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment

diffusion tensor imagingPROCEDURE

prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy

functional magnetic resonance imagingPROCEDURE

prior to CyberKnife, at 6 weeks, and 3 months after CyberKnife?, every 3 months for the first year, and every 6 months thereafter

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: DISEASE CHARACTERISTICS: * Histologically confirmed metastatic spinal tumor * Localized spinal metastasis, defined as one of the following: * Solitary spinal metastasis * Two contiguous spinal levels * No more than 2 adjacent spinal levels involved by a single tumor * Involvement of ≤ 3 separate sites (e.g., C5, T5, and T12) * Tumor size ≤ 5 cm PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Life expectancy ≥ 6 months * Negative pregnancy test * Fertile patients must use effective contraception * Must be ambulatory Exclusion Criteria: * Not pregnant or nursing * No spinal instability * No rapid neurological decline * No bony retropulsions causing neurological abnormalities * No total paraplegia for \> 48 hours * No psychological issues that would preclude completion of study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior treatment for spinal tumor that would result in potential overlap of radiotherapy fields * No treatment that is expected to exceed spinal cord tolerance or other regional normal tissue tolerance * No tumors that are exquisitely radiosensitive and controlled with conventional radiotherapy (e.g., lymphoma, leukemia, multiple myeloma, or germ cell tumors)

Locations (1)

Boston University Cancer Research Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Maximum tolerated dose - single fraction

Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery

Time frame: 6 weeks

Maximum tolerated dose - hypofraction

Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery

Time frame: 6 weeks

Secondary Outcomes

Assessment of pain

Pain as measured by the Brief Pain Inventory and Roland scale

Time frame: baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment

Spinal cord response

Spinal cord response as measured by functional MRI

Time frame: baseline and then at 6 weeks and 6 months after completion of treatment

Data from ClinicalTrials.gov

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